K082097 is an FDA 510(k) clearance for the DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE, a Suture, Surgical, Absorbable, Polydioxanone (Class II — Special Controls, product code NEW), submitted by Demetech Corp. (Miami, US). The FDA issued a Cleared decision on January 8, 2010, 533 days after receiving the submission on July 24, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K082097 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 2008 |
| Decision Date | January 08, 2010 |
| Days to Decision | 533 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW — Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4840 |